Podocon-25 is made from the extracts of certain plants (such as American mandrake, May apple, Duck's foot, Indian apple).

Podocon-25 (for the skin) is used to treat genital and anal warts in adults. Podocon-25 is for use only on warts outside the genitals and around the outside of the anus. This medicine topical is not for use inside the vagina, cervix, rectum, or urethra (the tube for passing urine out of your bladder).

Podocon-25 will not cure genital or anal warts and you may develop new warts during or after treatment. This medicine topical will not keep you from spreading genital or anal warts to other people through sexual intercourse or skin-to-skin contact.

Podocon-25 may also be used for purposes not listed in this medication guide.

You should not use Podocon-25 if you have diabetes, circulation problems, or if you also use steroid medicine.

Podocon-25 can cause birth defects. Do not use if you are pregnant.

You should not breast-feed while using this medicine.

Do not use Podocon-25 to treat any skin condition that has not been checked by your doctor.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not take Podocon-25 by mouth. This medicine topical is for use only on the skin. Do not use on open wounds.

Your doctor may want to give your first dose of this medicine in a clinic setting to quickly treat any serious side effects that occur. Stronger doses of podophyllum resin topical must be applied by a healthcare professional and not at home.

If you use this medicine at home, be sure you understand and follow all directions for safe use.

Wash your hands before and after applying this medicine. Also wash the genital wart before treating it.

Shake the solution (liquid) well just before each use.

Apply the medicine using the applicator provided, or with a clean cotton swab. Use a hand mirror if needed to see where you are applying the medicine. Apply directly to the wart and not the skin around it.

You can apply petroleum jelly (Vaseline) to the skin around the wart to keep the medicine from getting onto healthy skin. Allow the treated wart to dry completely before dressing.

Do not apply this medicine to a mole or birthmark. Do not use on a wart that is irritated, swollen, bleeding, or has hair growing from it. Do not apply to any wart that has recently had a biopsy.

Your doctor will tell you how long to leave this medicine on a treated wart. Leave the medicine on for the full treatment time. Then immediately wash off with soap and water, or a cotton ball soaked with rubbing alcohol.

Do not leave the medicine on for longer than prescribed.

A treated wart should turn pale or white within a few hours after you first apply Podocon-25. Then the wart should turn dark and possibly black within 24 to 48 hours, and shed off after about 72 hours.

Call your doctor if your wart has not improved after 72 hours.

Store at room temperature away from moisture, heat, and light. Podocon-25 may turn darker if it is exposed to light or heat.

You should not use Podocon-25 if you are allergic to it, or if you have:

• diabetes;

• circulation problems;

• if you are using steroid medicine; or

• if you are pregnant or breast-feeding.

Your doctor may perform a Pap smear or other medical tests to make sure this medicine is the right treatment for your condition.

To make sure Podocon-25 is safe for you, tell your doctor if you have:

• HIV/AIDS, or a weak immune system (caused by disease or by using certain medicine);

• circulation problems caused by diabetes; or

• peripheral vascular disease such as Raynaud's syndrome.

FDA pregnancy category X. This medicine can harm an unborn baby or cause birth defects. Do not use Podocon-25 if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medicine.

It is not known whether podophyllum resin topical passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Your skin can absorb large amounts of Podocon-25 if you apply too much, which may cause life-threatening side effects. Early signs may include confusion, hallucinations, stomach pain, diarrhea, muscle weakness, problems with balance or coordination, fever, sore throat, and unusual bleeding or bruising.

Podocon-25 can cause severe irritation. If this medicine gets in your eyes, rinse with plenty of water and call your doctor right away.

Avoid getting this medicine in your eyes, nose, mouth, rectum, vagina, or urethra.

Avoid allowing healthy skin to come into contact with a genital wart. Always wash your hands after touching a genital wart or applying this medicine.

Using Podocon-25 will not prevent you from passing genital or anal warts to another person during skin-to-skin contact or sexual intercourse. Talk with your doctor about safe ways to prevent transmission of genital warts during sex.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Topical medicine can be absorbed through the skin, which may cause side effects throughout the body. Call your doctor at once if you have:

• change in your mental state, confusion, agitation, seizure (convulsions), loss of consciousness;

• drowsiness or light-headed feeling (like you might pass out);

• weak or shallow breathing;

• severe constipation, little or no urinating;

• weakness, numbness, tingling in your arms or legs;

• easy bruising or bleeding (nosebleeds, bleeding gums), bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• upper stomach pain, loss of appetite; or

• chest pain, pounding heartbeats or fluttering in your chest, shortness of breath.

Some side effects of podophyllum resin topical may not happen right away, and some may last for a week or longer.

Call your doctor at once if you have severe burning, stinging, or irritation after using this medication.

Common side effects of Podocon-25 may include:

• swelling, redness, or tenderness of treated skin;

• itching; or

• burning pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.